Although the first patent for Eligard (leuprolide) has expired, other patents prevent a generic version from being produced until March 2020, provided there are no other outstanding patents or lawsuits. Leuprolide is not the same thing as generic Eligard. Rather, this is the "generic name," a term that is used to refer to the active ingredient in any drug.
Can I Buy Generic Eligard?
Eligard® (leuprolide acetate) is a long-acting injectable prescription medication used to help relieve symptoms of advanced prostate cancer. It belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) agonists, or sometimes luteinizing hormone-releasing hormone (LH-RH) agonists. Eligard injections may be given once every one, three, four, or six months.
Eligard is manufactured by Tolmar, Inc., for Tolmar Therapeutics, Inc. It is distributed by sanofi-aventis U.S. LLC. Eligard is currently under the protection of a patent that prevents any generic versions from being manufactured in the United States.
When Will Generic Eligard Be Available?
The first patent for Eligard expired in January 2011. This was the earliest predictable date that a generic version could have become available. However, there are other patents that may prevent generic versions of Eligard from being made. These other patents expire in March 2020.
Other circumstances may arise, however, that could extend or shorten the exclusivity period. This could include such things as lawsuits or additional patents for specific Eligard uses. Once the medication goes off-patent, there may be several companies that manufacture a generic Eligard drug.
Is Leuprolide a Generic Eligard?
Leuprolide is the active ingredient in Eligard, but is not a generic version of it. What can be confusing is that the active ingredient of any drug often is referred to as the "generic name."
The generic name is different from a generic version of a medicine. In order for there to be a generic version of a medicine, the original medicine must have gone off-patent and another company besides the original manufacturer must make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Eligard [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC;2011 March.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob. Accessed June 14, 2011.
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